Archive | Regulatory

Immunocore’s Lead Asset Tebentafusp Gains Fast Track Designation for Metastatic Uveal Melanoma

Source: Business Wire, May 2019 OXFORD, England & CONSHOHOCKEN, Pa.–(BUSINESS WIRE)–Immunocore Limited, a leading T Cell Receptor (TCR) biotechnology company, today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its development program, the investigation of tebentafusp (IMCgp100) for the treatment of patients who are HLA-A*0201-positive with previously untreated, metastatic uveal […]

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Posted in Melanoma News, Regulatory, Publications

Is your melanoma hot enough for immunotherapy?

Source: Science Daily, May 2019 Melanomas tend to be “hot” or “cold” — if they’re hot, immunotherapy lights melanoma tumors like beacons for elimination by the immune system; but 40-50 percent of melanomas are cold, making them invisible to the immune system, and patients with cold tumors tend to show little benefit from immunotherapies. The […]

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Posted in Melanoma News, Regulatory, Publications

FDA Approves Keytruda for Melanoma Patients After Tumor Resection

Source: Immuno-Oncology News, March 2019 The U.S. Food and Drug Administration has approved the use of Keytruda(pembrolizumab) as a treatment for melanoma patients with stage 3 disease — cancer cells have spread to the lymph nodes but not to distant organs — who have undergone complete resection of a tumor. The approval is based on data […]

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Posted in Melanoma News, Regulatory, Publications

NICE recommends new treatment for unresectable or metastatic melanoma with a BRAF V600 mutation

Source: Pharma Field, February 2019 NICE recommends new treatment for adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. Pierre Fabre welcomes the National Institute for Health and Care Excellence (NICE) decision to fund BRAFTOVI® (encorafenib) in combination with MEKTOVI® (binimetinib) for the treatment of adult patients with unresectable or metastatic melanoma […]

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Posted in Melanoma News, Regulatory, Publications